Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU) (VIEW-VLU)

Observational Study of the Effect of VarIthena® on Wound Healing in the Treatment of Venous Leg Ulcers Resulting From Chronic Venous Insufficiency

A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Drug: Varithena

Detailed Description

This 12 month, multicenter, open-label registry is designed to collect treatment and outcome data related to participants treated with Varithena for great saphenous vein (GSV) system and/or anterior accessory saphenous vein (AASV) incompetence resulting in VLU. Participant are treated per Investigator's Standard of Care (SoC) and in accordance with the Full Prescribing Information (FPI) and Instructions for Use (IFU). For participants with healed ulcers during the 12 month follow-up period, VLU recurrence information is collected.

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Oakville, Ontario, Canada, L6J7S2
      • Oakville Vascular
• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University
    • Sacramento, California, United States, 95817
      • University of California Davis Health
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • The Vascular Experts
  • Florida
    • Aventura, Florida, United States, 33180
      • Pines Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30306
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60625
      • Swedish Covenant Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mass General, Boston
  • New York
    • Buffalo, New York, United States, 14226
      • The Venous Institute of Buffalo
  • Ohio
    • Cincinnati, Ohio, United States, 45211
      • Mercy Health Cincinnati -West Hospital
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Totality
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Sciences Center at Houston
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV

Description

Inclusion Criteria:

• Men and women; age ≥18
• Investigator has selected Varithena® to treat participants classified C6 with chronic (≥3 months) VLU resulting from GSV and/or AASV incompetence
• Wound can be visualized in one plane to allow for image collection of the entire wound in one photograph, or if wound is circumferential, participant must be able to capture the entire wound using multiple photographs taken from directly above the wound (straight on)
• Reflux >500 milliseconds (ms) on duplex ultrasound
• Willing and able to collect wound photographs and data using an application installed on a tablet
• Willing and able to return for scheduled follow-up and wound care visits
• Ability to comprehend and sign informed consent form (ICF) and complete questionnaires

Exclusion Criteria:

• Contraindications to Varithena® 1% in accordance with the FPI
• Any serious concomitant disease, per physician's discretion, that confounds wound healing, including malignant changes of wound
• Concomitant heat ablation, or heat ablation of index leg within 6 weeks prior to treatment with Varithena®
• Significant arterial disease or ankle-brachial pressure index (ABPI) ≤0.8
• In the opinion of Investigator, wound would close within 12 weeks without additional treatment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Wound Perimeter	Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound.	Baseline to 12 weeks and to 12 months
Number of Wound Closure at 12 Weeks	Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform.	Baseline to 12 weeks
Time to Wound Closure	Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform.	Baseline to wound closure or to 12 months, whichever occurs first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	Mean change in pain on numeric pain rating scale (NPRS) compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "10". Higher scores mean a worse outcome.	Baseline to 12 weeks and to 12 months
Change on EQ-5D-5L Quality of Life Assessment	Mean change on 5-level EQ-5D (EQ-5D-5L) quality of life assessment compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "1". Higher score mean better outcome.	Baseline to 12 weeks and to 12 months
Change in VCSS	Mean change in Venous Clinical Severity Score (VCSS) from baseline to 12 month follow up. VCSS assesses nine common signs/symptoms of venous disease and each item is scored individually with a minimum score of "0" and maximum score of "3". The individual items are added together to assess change from baseline. Higher scores mean worst outcome.	Baseline to 12 weeks and to 12 months
Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date	Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform.	Baseline to 12 months
Number of Wound Recurrences	Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines.	Baseline to 12 months
Number of Ulcer Free Days	Mean number of ulcer free days defined as days from baseline to date of recurrence	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Michael Shao, MD, Swedish Covenant Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Actual): May 18, 2020
• Study Completion (Actual): September 28, 2020

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Vein; venous insufficiency; Ulcer; VLU; Venous; venous disease; GSV; AASV; Varicose Vein; chronic VLU
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer; Venous Insufficiency; Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol
• Other Study ID Numbers: BTG-001652-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes